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Analyzing FDA Guidance to Develop Adequate Reprocessing Instructions for Devices
Analyzing FDA Guidance to Develop Adequate Reprocessing Instructions for Devices

Our Price: $395.00

Product Code: WB-7164

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Includes 1 hour Windows Media Video File and PowerPoint presentations for immediate download.

The reprocessing of a medical device is a complex process that has evolved in recent years and increased significantly when multiple cases of the antibiotic resistant superbug carbapenem-resistant enterobacteriaceae (CRE) were linked to duodenoscopes, which had not been adequately sterilized. In response, the FDA released finalized guidance entitled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," which outlines expectations and recommendations for manufacturers to ensure the safe and effective use of reprocessed devices. Among the new expectations is a provision which stipulates that it is the responsibility of the manufacturer to validate and provide adequate reprocessing instructions that are comprehensive and user-friendly. While the guidance does contain various areas of ambiguity, such as the ideal size or design of a validation study, manufacturers must rigorously test and label new devices to clearly specify the appropriate reprocessing procedures.

  • In-depth review of guidance expectations and six criteria for clear reprocessing instructions
  • Developing labels with sufficient instructions on how to prepare device for next use
  • Defining human factors considerations in reprocessing
  • Incorporating effective reprocessing considerations throughout the product life cycle
  • FDA initiatives to enhance reprocessing oversight of devices


Jeffrey K. Shapiro
Hyman, Phelps & McNamara, P.C.

Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:

  • Regulatory Affairs
  • Reprocessing
  • Labeling

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